510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY TEMPLATE

A. 510(k) Number: k051578

B. Purpose for Submission: New device

C. Measurand: Cocaine/Cocaine Metabolite

D. Type of Test: Qualitative immunoassay

E. Applicant: Immunalysis Corporation

F. Proprietary and Established Names: Immunalysis Cocaine/Cocaine Metabolite ELISA for Oral Fluids

G. Regulatory Information: 1. Regulation section: 21 CFR ?862.3250, Cocaine/Cocaine Metabolite Test System 2. Classification: Class II 3. Product code: DIO 4. Panel: Toxicology (91)

H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: "The Immunalysis Cocaine/Cocaine Metabolite ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of Cocaine/Cocaine Metabolite at a cutoff of 20 ng/mL in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISALTM ORAL FLUID COLLECTION DEVICE ONLY. This in vitro diagnostic device is intended for clinical laboratory use only.

The Immunalysis Cocaine/Cocaine Metabolite ELISA Kit for Oral Fluids provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used."

3. Special conditions for use statement(s): See above.

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4. Special instrument requirements: This device must be read on a spectrophotometer that reads wavelengths of 450 nm and 620 nm.

I. Device Description: The device consists of a saliva collection device and a Cocaine/Cocaine Metabolite ELISA kit. An oral fluid specimen is collected by placing the collection device, a cellulose pad affixed to a propylene stem, under the tongue until approximately one milliliter saliva has saturated the pad. A blue indicator on the stem indicates when enough sample has been collected. The collector is transferred to a provided polypropylene tube containing preservative buffer (3 ml) and closed, ready for transport or storage. The ELISA assay is consists of 8-well microstrips coated with a sheep anti-Benzoylecgonine and a monoclonal anti-Cocaine antibody, a plate frame, conjugated Cocaine, negative and positive controls, a cut-off calibrator, TMB substrate, and stop reagent.

J. Substantial Equivalence Information: 1. Predicate device name(s): DRI Cocaine EIA Assay 2. Predicate 510(k) number(s): K960187 3. Comparison with predicate:

Item Analyte

Methodology

Similarities Device

Cocaine and Benzoylecgonine Immunoassay (EIA)

Predicate Cocaine and Benzoylecgonine Immunoassay (ELISA)

Item Test Matrix Cutoff

Differences Device

Oral Fluid 20 ng/mL

Predicate Urine 300 ng/mL

K. Standard/Guidance Document Referenced (if applicable): None referenced.

L. Test Principle: Enzyme-labeled drug and drug present in the sample compete for limited anti-cocaine antibody binding sites. Binding of the enzyme-labeled drug inhibits its reaction with the substrate, thereby influencing the rate of absorbance change measured by the instrument. The rate of absorbance change is proportional to the concentration of drug in the sample. Concentrations of controls and unknowns are calculated from the standard curve. Results are read at 450nm and 620 nm.

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M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Precision was tested by spiking negative oral fluid with 0, 10, 20, 30, and 40 ng/mL of Benzoylecgonine; this corresponded to 0, 50%, 100%, 150%, and 200% of the cutoff. One milliliter of the spiked fluids were pipetted onto the collection pad of the oral fluid collector then processed as per instructions.

Intra-assay precision was assessed with sixteen replicates of each concentration analyzed in one run:

Intra-assay Precision: Immunalysis Cocaine/Cocaine Metabolite for Oral Fluid Assay

Benzoylecgonine concentration (ng/mL)

0 10 (50% of cutoff) 20( 100% of cutoff) 30 (150% of cutoff) 40 (200% of cutoff)

Mean O.D.

2.4351 1.3943 1.2644 1.1456 1.0475

S.D. C.V.% B/B0 %

0.150 6.17 0.108 7.74 0.117 9.28 0.036 3.16 0.059 5.63

100 57.26 51.93 47.04 43.02

B= Absorbance of the mean concentration B0=Absorbance of the mean zero dose

Inter-Assay Precision Negative oral fluid was spiked with 0, 10, 20, 30 and 40 ng/mL of Benzoylecgonine. This corresponded to 0, 50%, 100%, 150% and 200% of the recommended screening cutoff for Benzoylecgonine in oral fluids. One mL of these different levels of Benzoylecgonine spiked oral fluids were pipetted on to the collection pad of the Quantisal Oral Fluid collector and the pad then placed in the transport tube with the preservative buffer.

Eight replicates of the five different Benzoylecgonine concentrations were analyzed in each run. This was repeated in 10 different assay runs, twice per day over a period of 5 working days.

Benzoylecgonine

MEAN S.D. C.V. %

10 ng/mL B/B0 %

58.93 3.253 5.52

20 ng/mL B/B0 %

48.47 3.190 6.58

30 ng/mL B/B0 %

43.18 2.98 6.90

40 ng/mL B/B0 %

39.74 3.168 7.97

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B= Absorbance of the micro-plate well for the particular concentration B0= Absorbance of the zero calibrator The B/B0 % is a dimensionless number that is independent of the Raw absorbance

Reproducibility of the oral fluid collection device was assessed by collecting oral fluid from 50 subjects with a pre-weighed collector and tube as per the package instructions. After the volume indicator turned blue, the collector and tube were weighed and the net weight of the saliva was determined and converted to volume (mLs).

Quantisal Oral Fluid Collection Device: Volume Adequacy Study

Avg. Std. C.V.

Mean

Mean

Vol. (mL) Dev.

+ 3 SD (mL) ? 3 SD (mL)

0.993 0.029 2.88% 1.079

0.907

These results support the sponsor's claim that the device collects 1 mL ? 10% saliva.

b. Linearity/assay reportable range: Not applicable. This assay is intended for qualitative use.

c. Traceability, Stability, Expected values (controls, calibrators, or methods): All calibrator and control stock solutions are prepared from commercially available DEA-exempt solutions; Benzoylecgonine concentration is confirmed by GC/MS analysis.

Claimed shelf-life of the oral fluid collection device and the ELISA kit and components is 24 months and 12 months respectively. Real-time studies are ongoing.

Stability of benzoylecgonine in the collection device was determined by spiking a pool of negative saliva with benzoylecgonine at a concentration around the cutoff and a pool at a concentration two-fold higher (2X). Samples were stored at 4?C or at room temperature. The specimens kept at room temperature were assayed in duplicate by GC-MS after 7 days, 14 days and 30 days; samples kept at 4?C were assayed were in duplicate by GC-MS after 14 days and 30 days. The sponsor's acceptance criterion was recovery of ? 20% of the initial value.

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Stability of Benzoylecgonine in Quantisal Buffer

STABILITY STUDY AT ROOM TEMPERATURE

Data point 0 7

14 21 30

BE Spike ng/mL

13.659 15.555 15.332 15.105 14.221

% of initial value

100 113.88 112.25 110.59 104.11

BE Spike 2X ng/mL

30.213 35.089 30.102 30.271 28.785

% of initial value

100 116.14 99.63 100.19 95.27

STABILITY STUDY AT 4?C

Data point 0

14 30

BE Spike ng/mL

13.659 13.078 17.367

% of initial value

95.75 127.15

BE Spike 2X ng/mL

30.213 33.162 28.088

% of initial value

109.76 92.97

A shipping study showed that benzoylecgonine spiked into saliva had acceptable recovery (? 15%) after transport.

d. Detection limit: See the Precision/Reproducibility section above for performance around the stated cutoff concentration.

e. Analytical specificity: Cross-reactivity of structurally similar compounds was determined by spiking concentrations of different drugs into synthetic oral fluid.

Compound

Concentration ng/mL

B/B0 BE % equivalents

ng/mL

Benzoylecgonine Benzoylecgonine Benzoylecgonine Cocaine Cocaine Cocaethylene Ecgonine Ecgonine Methyl Ester Norcocaine

10 20 40 20 40 20 2000 2000

1000

64.6 47.06 35.95 50.88 43.38 48.2 32.54 93.88

35.11

10 20 40 17.26 25.17 19.62 49.68 4.05

41.51

Percent (%) Crossreactivity

100 100 100 86.3 62.92 98.1. 2.5 0.2

4.1

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